The preclinical contract research organization (CRO) Admescope has acquired MetaSafe in a deal which will bolster its drug metabolism services for clinical phase projects.
The Centre for Process Innovation (CPI) has confirmed its role in a UK initiative to accelerate vaccine production and eliminate the need for cold-chain shipping.
Analytical testing concerns and ‘inadequate’ investigations into failed results were among the GMP deviations observed by the US FDA at IDT Australia Limited’s facility.
PPD Laboratories SVP says its been a substantial undertaking – for every company in the CRO industry – to meet the demand for biopharmaceuticals as the industry's pipeline continues to expand.
China’s pharmaceutical market has outpaced Japan’s to become the second largest market globally – as both aim to be the location of choice for companies developing new innovations, say Parexel consultants.
AMRI will support the development and manufacture of active pharmaceutical ingredients (API) and drug product for Phase I clinical studies under a seven-year contract with the NIH.
Celltrion has launched Bio CDMO, its new contract development and manufacturing business and part of the company's "open innovation strategy" to expand its drug pipeline portfolio.
The US FDA has agreed to recognise GMP inspections of API and drug product facilities carried out by Ireland's and Lithuania’s respective regulatory authorities.
Alcami Corporation is set to be acquired by MDP – a private equity firm which believes the CDMO could double or triple in size as a strong brand in a highly fragmented market.
Almac Group has reported a 19% growth in revenue to £531m ($709.86m) – a first for the company as it continues to invest globally and drive a strategy of strategically entering new markets, says finance director.
The US FDA has issued a warning letter to Chinese API maker Jilin Shulan Synthetic Pharmaceutical Co., citing lax electronic data security and inadequate batch records.
Drugmakers should allow time to test packaging and implement changes if needed, before the November DSCSA deadline, says contract packaging organization.
Syngene International has inked a non-exclusive partnering agreement with the emerging immuno-oncology company Zumutor Biologics after collaborating for more than a year.
Ergomed has added specialist pharmacoepidemiology services at its PrimeVigilance subsidiary to support increasing demand from regulators globally, says CEO.
Altasciences has entered into a strategic alliance with Altreos Research Partners to help clients navigate the “complexities of human abuse potential studies,” says CEO.
Several teams recently competed in the Popup Star clinical trial awareness contest to help raise grassroots awareness of clinical research as a care option within local communities.
The European Commission has angered the biopharma industry by proposing to relax the rules detailing when companies can manufacture biosimilars and generics in the region.
Recipharm has established a Brexit taskforce and plans to hire additional staff to navigate any potential effects of the UK’s departure from the EU in less than a year.
The Northern Ireland development agency Invest NI has awarded Fusion Antibodies a grant worth up to £213,000 ($283,231), which will help the CRO double its capacity and employee count.
Elligo Health Research has acquired ePatientFinder’s Clinical Trial Exchange technology platform and referring practice network as it aims to continue expanding its own network.
The global cancer drug market is expected to reach $200bn by 2022 as the industry experiences rapid changes in treatment guidelines and pathways – and increasing complexity, says Iqvia exec.
Academic research underpins many of the early success stories in continuous manufacturing. Now, Blair Brettmann and her team are working to write another chapter by applying electrospinning and other techniques to downstream processing.
Pharmaceutical companies could learn from the start-up methodology when adopting next-gen technologies, says founding editor-in-chief of WIRED Magazine UK.
LabConnect has completed phase one of three to increase its capacity for peripheral blood mononuclear cell (PBMC) processing at its facility in Johnson City, TN.
Lonza has added to its hepatocytes portfolio to provide researchers with the foundation to create “more physiologically relevant” in vitro models for liver disease research.
Bayer AG and Elsevier studied more than 1.6m adverse events to show how big data can be used to reduce animal testing and design trials "altered to potential risks," says researcher.
The US FDA has approved US WorldMeds LLC’s non-opioid treatment Lucemyra, adding another “tool to the toolbox” for withdrawal management, says American Society of Addiction Medicine.
Dr Reddy’s expects to have addressed all GMP violations at its Duvvada drug formulation plant and Srikakulam API facility within the next six weeks, says CEO.
WCG has opened a new office in Tokyo, Japan that will serve as a center of excellence for its patient engagement group and house the company’s clinical services division in Asia.
PPD and Evidera have joined MIT’s NEWDIGS initiative through which the CRO aims to scale sustainable, commercially viable tools to “drive more value faster.”
President Trump says he will sign the “big legislation” after the US House of Representatives passed the Right to Try Act – opponents of which warn lacks key patient protections.
GDP growth and low-priced generics in pharmerging countries have contributed to the growth of Asia Pacific's pharmaceutical market, which has surpassed Western Europe as the second largest globally, says report.
Astellas will contract out an internal testing laboratory to Eurofins Scientific, marking the CRO’s entry into biopharmaceutical product testing in Japan.
AstraZeneca is embedding Emulate’s Organ-on-Chips technology – and scientists – within its laboratories to further develop the technology as part of a strategic agreement, “with the overall goal to accelerate drug discovery,” says exec.
The global health research network today has announced the availability of TriNetX Research, a suite of analytics solutions designed to leverage real-world data during observational and outcomes research.
The newly-formed investment firm DORA Ventures has recapitalized Tedor Pharma, which recently completed a multi-million-dollar expansion of its manufacturing capabilities.
XenoGesis and BioAscent have teamed up to fill "a gap in the market" for integrated drug discovery services aimed at biotech, mid-sized pharma, and academic drug developers, says CEO.
Motif Bio plc has secured £10m ($14m) to support the potential commercialization of its lead candidate – iclaprim – which was granted FDA fast-track status in 2015.
